Modified Neuromuscular Transmission Monitor
FDA 510(k) K862149 · Puritan Bennett Corp.
510(k) numberK862149
Submission
- Device name
- Modified Neuromuscular Transmission Monitor
- Applicant
- Puritan Bennett Corp.
Overland Park, KS, US - Received
- June 4, 1986
- Decision date
- June 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXN – Stimulator, Nerve, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
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| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special | Easy Med Instrument Co., Ltd. | 05/13/2016SE |
| K143095 | MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional | Halyard Health, Inc. | 03/24/2015SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 11/06/2014SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | Sunmed, LLC | 03/28/2013SE |
| K111985 | Myoguide System Model 8008BXN · Traditional | Intronix Technologies Corp. | 12/30/2011SE |
| K110118 | Stimtrode Single Use Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 02/17/2011SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/03/2009SE |
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| K001646 | Puritan-Bennett 840 Ventilator System with Neomode OptionCBK · Traditional | 10/20/2000ST |
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| K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemBYJ · Special | 10/22/1999SE |
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Questions and answers
When was Modified Neuromuscular Transmission Monitor cleared by the FDA?
Modified Neuromuscular Transmission Monitor (K862149) received a 510(k) decision of Substantially Equivalent on June 19, 1986, 15 days after the submission was received.
What is the product code of K862149?
The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.